Recruitment

Recruitment Status
Completed

Inclusion Criteria

Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
Recreational athletes according to the american college of sports medicine (ACSM) definition
...
Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
Recreational athletes according to the american college of sports medicine (ACSM) definition
Familiar with the cycle ergometer exercise methodology
Written inform consent according to good clinical practice (GCP) and local regulations

Exclusion Criteria

Female volunteers taking oral or injectable contraceptives
Known hypertension
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
...
Female volunteers taking oral or injectable contraceptives
Known hypertension
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Known hypercholesterolemia (moderate/severe)
Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
Smokers
Relevant allergy or known hypersensitivity to the investigational drug or its excipients
Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Pregnancy and/or lactation
Liver and/or renal disease and/or vascular disease

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 40 years
Gender
Both males and females

Inclusion Criteria

Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
Recreational athletes according to the american college of sports medicine (ACSM) definition
...
Females must test negative for pregnancy
Male and female volunteers between 18 and 40 years old
Recreational athletes according to the american college of sports medicine (ACSM) definition
Familiar with the cycle ergometer exercise methodology
Written inform consent according to good clinical practice (GCP) and local regulations

Exclusion Criteria

Female volunteers taking oral or injectable contraceptives
Known hypertension
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
...
Female volunteers taking oral or injectable contraceptives
Known hypertension
Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills [intrauterine devices (IUDs)]
Known hypercholesterolemia (moderate/severe)
Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
Smokers
Relevant allergy or known hypersensitivity to the investigational drug or its excipients
Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
Pregnancy and/or lactation
Liver and/or renal disease and/or vascular disease

Tracking Information

NCT #
NCT02182882
Collaborators
Not Provided
Investigators
Not Provided